Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
Recruiting now · Not applicable
Conditions studied: Coronary Heart Disease
In brief
Prospective clinical study with two parts: PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects PART A: 12 000 subjects with stable CHD PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or personalised prevention program (PPP) i.e. 1000 subjects per arm. Study purpose is to assess the clinical value and cost-effectiveness of a personalised prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to prospectively validate risk screening biomarkers
Key facts
- Study ID
- NCT04433052
- Run by
- Tampere University
- People needed
- 12000
- Starts
- 2023-02-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2023-06-12
Who can join
Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Oulu University Hospital — Oulu, Finland (enrolling)
- Mehiläinen — Helsinki, Finland (enrolling)
- Helsinki University Hospital — Helsinki, Finland (enrolling)
- CCV-MVZ — Frankfurt, Germany
- Heidelberg University — Mannheim, Germany
- Technise Universität Munchen — München, Germany
- Herzklinik Ulm — Ulm, Germany
- Hellenic Red Cross Hospital — Athens, Greece
- Konstantopoulio Hospital — Athens, Greece
- Sismanoglion Hospital — Athens, Greece
- The Biomedical Research Foundation of the Academy Athens — Athens, Greece
- University Hospital Genova — Genova, Italy
- Multi Medica, Care and Research Institute — Milan, Italy
- Casilino Hospital Rome — Rome, Italy
- University Hospital Turin — Turin, Italy
- University of Bialystok — Bialystok, Poland
- Medical University of Silesia — Katowice, Poland
- Jagellonian University Medical College — Krakow, Poland
- University of Lublin — Lublin, Poland
- Nicolaus Copernicus University — Toruniak, Poland
- National Institute of Cardiology — Warsaw, Poland
- Hospital de Santa Cruz-CHLO — Carnaxide, Portugal
- Hospital do Espirito Santo — Lisbon, Portugal
- Hospital Santa Maria-CHULN/FMUL — Lisbon, Portugal
- Kuopio University Hospital — Kuopio, Finland
Full record on ClinicalTrials.gov
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